Food Safety News
An estimated 80 percent of all antibiotics in the U.S. are given to livestock, which raises concerns among some scientists about the fostering of antibiotic-resistant pathogens. But a study on antibiotics just published by researchers from the Stanford University School of Medicine might introduce a whole new concern to the equation.
Mice given antibiotics to treat Salmonella infections have been found to grow even sicker and start shedding more pathogens afterward. In fact, they begin to shed the same levels of bacteria as so-called “superspreaders,” the small minority of infected mice in the population who exhibit no signs of illness but spread large amounts of bacteria.
“We’ve shown that the immune state of an infected mouse given antibiotics can dictate how sick that mouse gets and also carries implications for disease transmission,” said Denise Monack, Ph.D., associate professor of microbiology and immunology at Stanford and the study’s senior author. “If this holds true for livestock as well — and I think it will — it would have obvious public health implications. We need to think about the possibility that we’re not only selecting for antibiotic-resistant microbes, but also impairing the health of our livestock and increasing the spread of contagious pathogens among them and us.”
It’s not entirely clear why some animals — and humans — are superspreaders while others are not. Approximately 10-30 percent of mice are superspreaders who will shed large amounts of Salmonella while exhibiting no signs of illness, while the remaining 70-90 percent shed only small amounts and sometimes develop symptoms.
In the Stanford study, mice given antibiotics went from shedding small amounts to much higher levels of Salmonella. Within days, they also became very ill and several died. But, when given the same antibiotics, the superspreaders continued shedding large amounts of bacteria without any ill effects.
The researchers found that, compared to the normal mice, the superspreaders had dampened immune responses, which explained why they didn’t get sick. Instead of fighting off the infection, their immune systems tolerated it.
“Their immune cells have been rewired and aren’t responding to the inflammatory signals in the intestines the same way,” said Smita Gopinath, Ph.D., the study’s lead author.
And with the mice who do experience symptoms of illness, the antibiotics do exactly the opposite of what they’re intended to do.
These same conditions have not been observed in humans, but it’s an area worth studying, the researchers said.
In the 75 weeks between the indictment and the start of the trial, and during the eight-week jury trial, the criminal cases against former Peanut Corporation of America (PCA) executives have largely played out in public.
But since the jury handed down guilty verdicts a month ago, many of the orders, motions, and documents filed in the case have been sealed from public view and for reasons that are often unclear.
The 30-day deadline for post-trial motions imposed by U.S. District Judge W. Louis Sands passed Sept. 19. The three defendants convicted by the jury all want Sands to either overturn the verdicts or order new trials. More than a dozen other court documents filed since the end of the trial are sealed, including orders from the judge.
No sentencing date is known to have been set. Pre-sentencing reports for the federal courts are conducted largely in secret, and it’s possible that references to those investigations are among the sealed files that are piling up.
Among the motions that are public, here’s what we’ve learned since 60-year-old Stewart Parnell, chief executive and owner of the now-defunct PCA; his 55-year-old brother Michael Parnell, a peanut broker, and Mary Wilkerson, PCA’s quality assurance officer, were found guilty on various felony charges:
- As reported by Food Safety News on Oct. 8, the Parnell brothers jointly filed a motion for a new trial based on reports that some jurors may have done their own research on the 2008-09 Salmonella outbreak that led to the investigation that resulted in the 76-count indictment against the defendants.
- Stewart Parnell, found guilty on 67 counts charged, has moved for a judgment of acquittal or a new trial. His attorneys argue that there is insufficient evidence to support the jury’s verdict. Parnell says he did not intentionally ship tainted food, believed retesting was a legitimate process, and that his Blakely, GA, operations manager was “following protocol.”
- Michael Parnell, found guilty on 30 counts charged, has moved for a judgment of acquittal. His attorneys argue that since the jury found their client not guilty on multiple charges involving shipping misbranded food or participating in a conspiracy or fraudulent scheme, it’s inconsistent with the convictions.
- Mary Wilkerson, found guilty on one of two counts of obstruction of justice charged, also wants a judgment of acquittal. Her court-appointed attorney, Thomas G. Ledford, argues that the evidence at trial shows confusion about whether Wilkerson was even involved in the incident upon which the charge was made.
That incident concerns Stewart Parnell telling an inspector that, if any samples came up positive, Wilkerson would know about it, but the question involved a time period before she was the QA officer for PCA at Blakely, GA. A Feb. 3, 2009, memo from FDA’s Janet Gray quotes Parnell as saying that “someone” at Blakely would remember if there were any positives, but that relates to a Jan. 20, 2009, phone conversation with Parnell in which he did not mention Wilkerson.
“There was no mention of Mary Wilkerson by the name or reference to her position in this quote from Stewart Parnell although this was the basis of Count 73 in the indictment against Wilkerson,” Ledford writes. The Albany, GA, attorney says that Parnell was misquoted in Count 73 of the indictment, and he says that is the basis for the “very serious felony charge of Obstruction of Justice.”
Ledford states that Wilkerson’s name is not even mentioned in the memo of the conversation by Gray and that, “at some point in time,” the word “someone” was replaced with “Mary” because the indictment needed a “genuine warm body.”
Ledford further argues that the remaining obstruction count is vague and ambiguous in that Wilkerson’s response was to a question that did not clarify the time period involved, and the government has never been able to provide a recording, time log, video, affidavit, statement or any other type of record of their interview with the defendant who supposedly obstructed them.
“No such credible evidence was presented by the Government at any time during the Trial, which would have been sufficient for a conviction and therefore, the Defendant argues that no reasonable jury could possibly find guilty beyond a reasonable doubt on Count 73,” Ledford writes.
Stewart Parnell’s defense team from Gentry Locke Rakes & Moore in Roanoke, VA, is making multiple arguments on behalf of their client. They argue that the testimony of Daniel Kilgore, the PCA operations manager at Blakely, “was impeached through cross-examination and should be ignored.”
Kilgore has a plea agreement with the government and also awaits sentencing. He was indicted separately in February 2013, and his extensive testimony at trial should result in getting favorable consideration at sentencing.
The Virginia attorneys also charge that rebuttal and closing arguments by Department of Justice (DOJ) Attorney Patrick Hearn, one of the case’s three prosecutors, was improper for bringing up “food safety.”
“The stark implication of Mr. Hearn’s statements was that if the jury did not convict Mr. Parnell that innocent people would fall ill from tainted food,” the defense attorneys wrote. They compared it to a prosecutor bringing up the “War on Drugs,” which courts have found to be improper.
They also argue that much of the evidence introduced through the testimony of Samuel Lightsey, the former Blakely plant manager who was also a government witness, was improper because it pre-dated his arrival at the facility.
Finally, Stewart Parnell’s attorneys argue that there were enough trial mistakes to either overturn the verdicts or order a new trial based on “cumulative error.”
Approximately half of all FDA class-I drug recalls since 2004 have involved dietary supplements adulterated with banned pharmaceutical ingredients.
Previous studies have found that dietary supplements remain on store shelves even after FDA recalls, but a new study just published in the Journal of the American Medical Association (JAMA) found that 68 percent of the dietary supplements analyzed still contained the banned drugs at least six months after their recall.
“Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the US marketplace,” wrote Dr. Pieter A. Cohen of Harvard Medical School and his colleagues. “More aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both will be required if sales of these products are to be prevented in the future.”
The products studied were recalled due to adulteration with pharmaceutical ingredients between Jan. 1, 2009, and Dec. 31, 2012, and available for purchase in July or August 2013. The supplement name, manufacturer, and distributor listed on the purchase also had to be identical to the information provided in the FDA recall.
Researchers analyzed 27 of the 274 dietary supplements recalled by FDA in 2009-12 that met their criteria. They used the same methods FDA field laboratories do to screen for adulterants.
Eighteen of the supplements contained a pharmaceutical adulterant. All but one of these had the same drug identified by FDA, and six of them had additional banned ingredients not identified by FDA.
The banned substances included sibutramine, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor, and various anabolic steroids.
The researchers acknowledged certain limitations on their study — the main one being that although they made every effort to purchase recently manufactured supplements, “it is not known if all supplements were manufactured after the FDA recall.”
Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs from 2011-14 and current CEO of the National Products Association (NPA), said that the implications of the study are “largely overblown.”
He was particularly critical of the fact that only 27 substances were tested for the study.
“I think this study aims to say there aren’t adequate laws on the books,” Fabricant said. But, in his three years with FDA, he said the agency showed this wasn’t the case. “I think we showed that the laws certainly work and have a lot of value to them.”
He added that dealing with companies that continue to break the law calls for strong enforcement tools. Because supplements are generally dealt with as drugs within FDA, he said it might be worthwhile to direct some of the food tools, such as administrative detention and mandatory recall authority available under the Food Safety Modernization Act, toward this issue.
Fabricant’s message to consumers is that, “If product claims sound too good to be true, they likely are and that should be a red flag.”
The JAMA-published study was supported, in part, by a grant from Consumers Union.
The rule replaces the traditional petitioning process for a manufacturer seeking GRAS status for an additive with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS.” FDA’s website acknowledges that the agency began accepting GRAS notices in 1998 even though the procedure was not yet final.
In May, FDA filed a motion to dismiss the suit, arguing that CFS has not identified any member of the organization “who has actually suffered this clearly speculative injury” and that “the proposed rule does not cause the alleged injuries from consumption of food substances.”
The settlement agreement, pending approval by the court, will require FDA to finalize the GRAS rule by August 2016. If FDA does not meet this deadline, CFS can ask the court to order the agency to fulfill its commitment and issue the rule.
“This is a major victory for consumers and the public,” said Donna Solen, CFS senior attorney. “For more than 17 years, FDA has imposed a lax regulatory system on consumers without affording them their right to participate in the rulemaking process. This is a violation of federal law that will come to an end as a result of this settlement agreement.”
The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives used in food today are being used based on undisclosed GRAS safety determinations. A recent report from the organization explored more details about chemicals reported as GRAS based solely on a company determination.
In August, the Grocery Manufacturers Association announced its plan to make the process for companies’ GRAS determinations more transparent.
Although the matter of this particular FDA rule may be settled, conversations surrounding GRAS are unlikely to die down.
Speaking to reporters at the United Fresh Washington Conference in September, Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said that the agency would like to do more to ensure that it can vouch for the safety of GRAS substances, but that there are “some big resource constraints.”
“Post-market surveillance is something we think is necessary and needs to be enhanced for both food safety and consumer confidence perspectives,” Taylor said, adding that although FDA’s food additive program has been funded to do the market-entry work, it “hasn’t really been funded to do the post-market surveillance.”
As the new Modernization of Poultry Inspection rule went into effect Monday, the Pew Charitable Trusts and Center for Science in the Public Interest released their review of global meat and poultry inspection systems. They recommended that U.S. policymakers begin a broader, data-driven effort to update the Department of Agriculture’s inspection system.
Traditional slaughter inspection methods for beef, pork and poultry are based on the Federal Meat Inspection Act of 1906 and the Poultry Products Inspection Act of 1957.
“These techniques focus largely on ensuring that food comes only from healthy animals,” states the report entitled, “Meat and Poultry Inspection 2.0.” “They are much less effective in protecting consumers from the modern-day hazards that commonly contaminate meat and poultry products.”
Sandra Eskin, director of food safety at Pew, compares the U.S. inspection system to a house built in 1906 and frequently redecorated since then. Maybe what we should do instead is knock the house down and build a new one, she suggested.
The report surveyed ante- and post-mortem inspection requirements in Australia, Denmark, the Netherlands, New Zealand and Sweden, plus efforts by the European Food Safety Authority (EFSA) to modernize meat inspection. The review was intended to identify innovations in information management and integrated surveillance that could offer improved protections for U.S. consumers.
One of the key findings in the report is that robust data collection, analysis and sharing are fundamental components of international efforts to transform existing inspection practices into a modern, risk- and science-based inspection system.
The EFSA expert panel convened in 2010 to study approaches to inspections concluded that microbial hazards should be addressed from farm to fork with good manufacturing practices, good hygiene practices, and HACCP systems.
With food chain information, for example, inspectors can identify high-risk animals, herds and flocks before they enter facilities so that slaughter practices, control measures and monitoring can be targeted appropriately.
“Meat and poultry inspection at slaughter is essential for ensuring human health and the health and welfare of food animals, but it needs to be modernized to take into account changes in the most relevant public health hazards,” reads the report by Pew and CSPI.
Their review also revealed that none of the countries sends meat inspectors to every meat and poultry slaughter and processing plant every day, as is done in the U.S. Some countries use private or quasi-governmental inspectors in their meat and poultry inspection systems, while others have completely turned over certain aspects to industry.
Based on their findings, Pew and CSPI recommend that the U.S. commission comprehensive scientific assessments to evaluate its existing meat inspection approaches and alternatives for modernization, that a more significant effort to improve data collection related to meat and poultry production and testing be undertaken, and that the U.S. think about incorporating food chain information into its meat and poultry inspection system.
“While CSPI supports modernizing meat and poultry inspection, USDA has adopted an incomplete solution without the scientific backing necessary to assure consumers that poultry will carry fewer hazards, like Salmonella and Campylobacter,” said CSPI Food Safety Director Caroline Smith DeWaal.
One criticism of the new Modernization of Poultry Inspection rule, which establishes the New Poultry Inspection System (NPIS), is that while it does require enhanced sampling for all poultry plants, it doesn’t specify which pathogens the plants should be testing for.
Eskin told Food Safety News that USDA’s Food Safety and Inspection Service (FSIS) is dedicated to improving public health, but that the agency’s proposals, including the poultry inspection rule and Salmonella Action Plan, are “baby steps and they need bigger leaps.”
“We welcome and appreciate the report from Pew and CSPI, which supports many of our efforts to modernize and strengthen America’s food safety system,” a FSIS spokesperson told Food Safety News. “As the Government Accountability Office acknowledged today, FSIS ‘has moved to an increasingly science-based, data-driven, risk-based approach’ to protecting public health. This will help us prevent thousands of illnesses every year.”
GAO published a 67-page report entitled, “USDA Needs to Strengthen Its Approach to Protecting Human Health from Pathogens in Poultry Products,” on Monday. It recommends that FSIS take action to reduce pathogen contamination on chicken and turkey products, make sure that agency food-safety standards are being met, and better assess whether on-farm practices are effective in reducing pathogens in live poultry.
The Colorado Department of Public Health and Environment (CDPHE) called Monday for a ban on marijuana edibles, including brownies, cookies, and most candies, but was quickly pulled back after public health officials said they did not realize that voter-approved Amendment 64 makes legal all forms of marijuana.
In a statement, the department said its recommendation for a ban was “just that” and that the public health agency does not represent Governor John Hickenlooper on the issue and did not run its desire to prohibit edibles past his office.
The move for a ban on edibles within his administration puts the Democratic governor in a dicey position. He did not campaign against Amendment 64 when it was on the ballot, but said he was against it.
Colorado’s booming marijuana industry has raised money for his reelection, but, in a recent debate, he advised other states to keep the lid on recreational pot. CDPHE made the recommendation for a ban on edibles at a meeting for marijuana industry stakeholders, probably causing many to wonder whether the governor was behind it.
According to the polls, Hickenlooper is essentially tied with former GOP Congressman Bob Beauprez, who has opposed recreational marijuana.
Dr. Larry Wolk, CDPHE chief medical officer, was left trying to explain what happened.“Considering only the public health perspective, however, edibles pose a definite risk to children, and that’s why we recommended limiting marijuana-infused products to tinctures and lozenges,” Wolk said. He added that the department was trying to put together a recommendation “only in consideration of the public health challenges of underage marijuana ingestion. It does not account for the dynamics of the black market or the guidelines set forward by Amendment 64.” By withdrawing its recommendation, CDPHE is being trumped by both politics and the language of Amendment 64, which made the Colorado Department of Revenue the only regulatory authority for marijuana under the voter-approved initiative that legalized recreational marijuana sales in Colorado beginning just 10 months ago.
It’s unlikely, however, that the revenue department would ever have accepted such a ban, both because it is apparently not allowed by the language of Amendment 64 and the fact that revenue’s marijuana enforcement unit has its own fix coming.
Erratic dosing levels for some edible marijuana products have been the source of both tragic and comedic incidents since recreational sales got underway in Colorado.
Revenue previously announced plans for February 2015 implementation of new packaging and other changes. Those changes include setting a THC level of 10 milligrams for each serving of edible marijuana, with the maximum for the entire product of 100 milligrams. The new regulations are supposed to address the packaging, labeling and portioning of edible marijuana products so that they have a distinctive look.
Edibles were reportedly a factor in two deaths early this year, in addition to numerous emergency room trips involving children. Some comic incidents have also occurred, such as a New York Times columnist who took some edible marijuana and apparently never found a way out of her Denver hotel room.
The latest U.S. labeling rules, put into effect in 2013, require meat sold in grocery stores to indicate the country, or countries, where the animal was born, raised and slaughtered.
According to a WTO report released on Monday, the labeling rules unfairly discriminate against meat imports and give the advantage to domestic meat products. But the WTO compliance panel also found that the labels do provide U.S. consumers with information on the origin of their food, countering Canada and Mexico’s assertion that the labels do not serve their intended purpose.
Back in November 2013, Agriculture Secretary Tom Vilsack said that the WTO should have the final say on COOL, suggesting that the U.S. might give in to whatever the WTO compliance panel determined.
This is the second time the WTO has ruled against the U.S. in this dispute. After passing mandatory COOL rules in 2008, the U.S. amended COOL in 2012 following an earlier WTO ruling against them.
The Canadian cattle and hog industries say that COOL has cost them combined losses of more than $900 million USD. If the COOL rules persist, the Canadian government has threatened to place tariffs on U.S. meat imports, along with products such as wine, potatoes and orange juice.
The U.S. beef industry has strongly opposed COOL, while organizations representing consumers say that grocery shoppers deserve to know where their meat originates.
“COOL is a failed program that will soon cost not only the beef industry, but the entire U.S. economy, with no corresponding benefit to consumers or producers,” said Bob McCan, president of the National Cattlemen’s Beef Association, in a statement. “… We look forward to working with Congress to find a permanent solution to this issue, avoiding retaliation against not only beef, but a host of U.S. products.”
In a joint statement, the North American Meat Association and the American Meat Institute also lauded the WTO’s decision.
“USDA’s mandatory COOL rule is not only onerous and burdensome on livestock producers and meat packers and processors, it does not bring the U.S. into compliance with its WTO obligations,” the joint statement read. “By being out of compliance, the U.S. is subject to retaliation from Canada and Mexico that could cost the U.S. economy billions of dollars.”
The consumer group Food & Water Watch called the ruling a threat to consumers’ right to know.
“The WTO’s continued assault against commonsense food labels is just another example of how corporate-controlled trade policy undermines the basic protections that U.S. consumers deserve,” said Food & Water Watch Executive Director Wenonah Hauter in a statement. “The United States should appeal the ruling and continue to fight for sensible consumer safeguards at the supermarket.”
Congresswoman Rosa DeLauro (D-CT) also spoke out against the ruling and urged the Office of the U.S. Trade Representatives to appeal the ruling.
“Accurate information is essential in a competitive, free market and COOL provides consumers with essential information about the origin of their food,” DeLauro said in a statement. “If this ruling stands, U.S. ranchers will not be able to differentiate their products with a U.S. label and consumers will not have the information they need at the point of purchase.”
The Office of the U.S. Trade Representatives said that all options were being considered, including the possibility of appealing the ruling.
“A negotiated solution, not further litigation at the WTO, is the most realistic path to getting this issue resolved in the near term,” said a spokesperson for the office. “Allowing this case to wait for resolution in Geneva will only prolong the market uncertainty we’ve seen on all sides of this issue.”
The U.S. Government Accountability Office (GAO) is recommending that the Department of Agriculture’s Food Safety and Inspection Service (FSIS) take action to reduce pathogen contamination on chicken and turkey products, make sure that agency food-safety standards are being met, and better assess whether on-farm practices are effective in reducing pathogens in live poultry.
In a 67-page report publicly released Monday entitled, “USDA Needs to Strengthen Its Approach to Protecting Human Health from Pathogens in Poultry Products,” GAO suggests that USDA take four specific actions:
1. To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, the Secretary of Agriculture should direct the Administrator of FSIS to expeditiously develop Salmonella performance measures with associated targets for young turkey carcasses to monitor whether activities to bring plants into compliance with the standards are meeting the agency’s goals.
2. To help ensure that the Food Safety and Inspection Service (FSIS) efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, once FSIS revises its Salmonella standards for ground chicken and ground turkey, the Secretary of Agriculture should direct the Administrator of FSIS to expeditiously develop Salmonella performance measures with associated targets for these products to monitor whether activities to bring plants into compliance with the standards are meeting the agency’s goals.
3. To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, once FSIS establishes plant compliance categories for Campylobacter in young chicken and turkey carcasses, the Secretary of Agriculture should direct the Administrator of FSIS to expeditiously develop Campylobacter performance measures with associated targets for these products to monitor whether activities to bring plants into compliance with the standards are meeting the agency’s goals.
4. To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, in future revisions of the compliance guidelines on controlling Salmonella and Campylobacter, the Secretary of Agriculture should direct the Administrator of FSIS to ensure the inclusion of information on the effectiveness of each recommended farm practice to reduce these pathogens in live poultry.
GAO, an independent legislative-branch agency, noted that FSIS faces several challenges in reducing Salmonella and Campylobacter contamination in poultry products: “These include limited control outside of slaughter plants, pathogens not designated as hazards, limited enforcement authority, absence of mandatory recall authority, outdated or nonexistent standards, insufficient prevalence estimates, the complex nature of Salmonella, and limited Campylobacter research and testing.”
These perceived FSIS challenges were based on GAO’s own analyses and the views of 11 stakeholder groups, academic researchers, and FSIS officials, the report stated, adding, “… the stakeholder groups representing consumers and those representing industry generally had differing views.”
On Monday, a spokesperson for FSIS indicated that the agency was in accord with the report’s overall findings.
“FSIS appreciates the GAO’s acknowledgment that FSIS is putting in place an ‘increasingly science-based, data-driven and risk-based approach’ to protecting public health. We agree with the report’s recommendations and will continue implementing them,” the spokesperson stated.
USDA officials had previously reviewed a draft copy of GAO’s report, and a five-page response dated Sept. 15 from Brian Ronholm, the agency’s Deputy Under Secretary for Food Safety, is included in the appendices.
Among other comments, Ronholm acknowledged that while FSIS “has not established formal performance measures for all poultry product and pathogen combinations … ,” developing such measures is a “formal, rigorous process” that can take several years to accomplish.
He further stated that, despite not having formal performance measures in place, FSIS does set goals and track progress and, as an example, makes public the percentage of Campylobacter positives in turkey establishments along with other information so that the agency and regulated industry may adjust food-safety activities in response to trends.
Ronholm also clarified that some data on the incidence of Salmonella illnesses in humans which GAO used in its report included all such data CDC tracks with its FoodNet program and not just those illnesses related to FSIS-regulated products (which include meat, poultry and eggs).
“Salmonella attribution to FSIS-regulated products has actually decreased over the past 5 years,” he noted.
Finally, Ronholm addressed the four specific GAO recommendations in detail and wrote that FSIS concurs with each one.
The two U.S. senators who requested the GAO report this past March responded to its findings on Monday. Sens. Kirsten Gillibrand (D-NY) and Dianne Feinstein (D-CA) released a joint statement, along with their Senate colleague, Richard Durbin (D-IL), noting that they had written to Agriculture Secretary Tom Vilsack to urge that stronger Salmonella and Campylobacter standards be set for poultry.
In their letter, the senators reminded Vilsack that he had committed to moving forward with such pathogen standards by the end of the federal fiscal year, which was Sept. 30, but that the standards had not yet been proposed.
“Routine testing done in 2013 by the Department found that over 40 percent of ground chicken tested positive for Salmonella. A national study completed by the Department in 2012 found that 26 percent of poultry parts tested positive for Salmonella and 21 percent tested positive for Campylobacter. As of today, there are no standards for poultry parts and the standards for ground poultry have not been updated since 1996,” they wrote.
In recently posted U.S. Food and Drug Administration (FDA) warning letters, three producers were cited for holding animals “under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”
Papas Dairy of North Bangor, NY, was cited for illegal drug residue in a calf sold for slaughter. David T. Phillips’ beef-raising operation in Midway, KY, was cited for oxytetracycline, florfenicol, ciprofloxacin and flunixin residues in the tissue samples of a bull transported for slaughter.
And FDA stated that Neely Livestock in Murfreesboro, TN, sold a pig for slaughter that had penicillin in its muscle and kidney tissues and spectinomycin residue in its kidney tissue. FDA has established a tolerance of 0.0 ppm for penicillin residues.
A seafood-processing facility in Lynn, MA, was found to have a “a serious violation” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. On July 30, an FDA investigator saw Kettle Cuisine employees cut open underweight or defective finished containers of Manhattan clam chowder and add them back into the holding tank, the letter stated. In an August response to the agency, the company indicated that it has stopped this practice.
FDA warned that the company’s response “did not address our observation related to not identifying the food safety hazard of pathogenic bacteria introduction after cooking that is reasonably likely to occur at the hot filling, container sealing, and container cooling steps.”
Grandmas Food Products in Muvattupuzha, Kerala, India, failed to establish scheduled processes of its acidified foods in accordance with regulations, FDA stated. In addition, the agency said that plant personnel in acidification, pH control, heat treatment, or other critical factors of the operation are not under the operating supervision of a person who has attended a school approved by the agency.
Burnette Foods of East Jordan, MI, also faced “serious violations” of the regulations for acidified foods, including deviations from filed scheduled process for its Shelf Stable Hummus.
Rongcheng Shidao Guangxin Food Co.’s low-acid canned seafood processing facility in Rongcheng, China, was cited for serious violations of low-acid canned food regulations. Issues included some missing details in the scheduled process for sardines in oil, failing to maintain proper records, and failing to check container handling equipment frequently to prevent damage.
FDA also considered the company’s Hyper Harbor brand for Sardines in Tomato Sauce with Chili and Sardines in Brine misbranded because they failed to declare the acceptable market name for the fish used on the label’s list of ingredients.
Lastly, a review of the label and website for Artisana Coconut Butter Whole Coconut Flesh produced by Premier Organics of Oakland, CA, led FDA to consider the product misbranded because the label bears “nutrient content claims but do not meet the requirements to make the claims.”
FDA explained that the label reads “The Art of Healthy Foods” and “healthy…food…” in connection with the statement “preserves the life-essential fatty acids, enzymes, vitamins and minerals,” but that the coconut butter doesn’t meet the requirements for use of the nutrient content claim “healthy.”
Each company was given 15 days to respond to the concerns raised by FDA in the warning letters.
(This article by Tom Karst, national editor of The Packer, was first published Oct. 19, 2014, and is reposted here with his permission.)
ANAHEIM, CA—The last word on food safety regulations for the produce industry won’t be written next year, even though the Food and Drug and Administration (FDA) has committed to publish final versions of the produce safety and preventive controls rule for food facilities next year.
FDA officials speaking at an Oct. 17 Fresh Summit workshop on food safety regulations said the process of refining and educating growers and industry will continue for years and they urged industry leaders to continue their dialogue with the agency.
FDA has been working with the produce industry in a collaborative way on food safety since the late 1990s, said Michael Taylor, deputy commissioner for foods and veterinary medicine for FDA. He credited both the Produce Marketing Association (PMA) and other industry groups in that process.
Even though some of the final food safety regulations will be on the books next year, Taylor said it won’t be all over then. “We’ve got to see this as a long process,” he said. Taylor urged further dialogue and input from industry on the recently issued supplemental rules that are open for comment until mid-December.
Taylor said the recently issued supplemental rules addressed microbial standards for agricultural water, clarification of operations subject to the produce safety rule, relaxation of raw manure rules and changes in qualified exemptions from the produce safety rule.
The exemption issue is controversial, he said, with some groups favoring no exemptions and others favoring more exemptions. FDA has found room for some exemptions , but he said smaller producers not subject to the rule are still subject to existing adulteration standards in food law.
“At the end of the day, all growers are accountable for food safety,” Taylor said. “The question is, how do we get there?”
Looking ahead toward implementation of the food safety regulations, Taylor said that the agency is committed to education before regulation.
“Most people want to make (food safe), what they need is clarity about what is expected,” he said. Taylor noted that many leaders attending the standing-room-only session have contributed to produce safety standards already in place.
Other growers need help to achieve acceptable food safety standards, and Taylor said FDA is committed to help those growers as part of the agency’s compliance strategy.
The process, aided by a recent cooperative agreement between FDA and state departments of agriculture, will be a long-term project that will extend a decade or longer, he said.
At the same time FDA and states will collaborate on public oversight, Taylor said that most of the verification and accountability of new food safety rules will come from private sources such as third-party audits.
Meshing that private oversight with public oversight will be an important test of making the produce safety rules effective, he said.
Samir Assar, director of the produce safety staff at FDA, addressed changes in water testing language and raw manure regulations in the recently released supplemental rulemaking.
PMA’s Bob Whitaker, chief science and technology officer, and Jim Gorny, vice president for food safety and technology, moderated the panel including FDA officials and industry panelists Walter Ram, vice president of food safety, The Giumarra Companies, Los Angeles, CA; Courtney Parker, vice president of salad quality and global food safety, Chiquita Fresh Express, Salinas, CA, and Mike Villaneva, technical director, California Leafy Green Marketing Agreement, Sacramento, CA.
In the question-and-answer period, Parker asked FDA about the science behind the mandate to test agricultural water for generic E. coli.
Assar said that generic E. coli is a good indicator for fecal contamination, but he said the agency was open to science that would suggest another standard that could be more appropriate.
Villaneva said there is grower confusion about its new testing scheme for water, and Assar acknowledged that growers will need technical assistance and guidance to perform the water tests.
Ram questioned how FDA will evaluate the significance of a positive Listeria test at a distribution center for produce, and Assar said the context of the find is important.
“It could lead to the conclusion there is a public health issue,” he said.
Parker asked if FDA would be investing in research projects on produce safety such as the proper science necessary for the application of raw manure. Taylor suggested that FDA will have little budget to support research projects, but he added that the agency could be engaged in helping to advise the direction of research projects funded by USDA or other agencies.
Eugene D. Corda, 65, the top yardman responsible for receiving cattle and moving them for inspection and slaughter at Rancho Feeding Corporation’s slaughterhouse in Petaluma, CA, has very likely become a government witness.
Under terms of a sealed plea agreement with government attorneys, Corda has now pleaded guilty to just a single count contained the Aug. 14 indictment that charges key Rancho personnel with a conspiracy in processing cattle that should have been condemned for a cancerous eye condition or other diseases.
Corda was one of three men charged in the original indictment. He originally pleaded not guilty to the charges, as have Rancho co-owner Jesse J. Amaral Jr., 76, and Felix Sandoval Cabrera, 55. Separately, the other Rancho co-owner, Robert Singleton, 77, has also pleaded guilty to one count of distributing adulterated, misbranded and uninspected meat.
Corda and Singleton will likely testify as government witnesses against Amaral and Cabrera in a U.S. District Court criminal trial to be held in San Francisco early next year. The roles the four men allegedly played in moving beef from cows with cancerous eyeballs past USDA meat inspectors and into the market for human consumption are contained in court documents.
Amaral, Rancho’s president and general manager, was in control of the day-to-day operations at the Petaluma slaughterhouse located 60 miles north of San Francisco. Singleton’s role was to buy cattle and supervise processed beef for distribution.
Cabrera, Rancho’s foreman, was responsible for the staff and the “kill floor,” including being responsible for “knocking cattle,” which means stunning them immediately prior to slaughter.
As yardman, Corda was responsible for receiving cattle and moving them to the proper areas for inspection and slaughter.
Singleton bought cattle from both auction houses and individual farmers and ranchers in Northern California and Nevada.
“Some of the purchased cattle exhibited signs of epithelioma, that is lumps or other abnormalities around the eye, and were less expensive than cattle that appeared completely healthy,” government attorneys claim.
When cattle arrived at the Petaluma slaughterhouse with these eye conditions, Corda or another Rancho employee would place them in pen 9A, the documents state. The owners were in charge of determining the order in which cattle were processed for inspection and slaughter.
When instructed, Corda moved cattle into the pen designated for ante mortem inspection by the USDA veterinarian or Food Safety and Inspection Service (FSIS) personnel. Cattle passing ante mortem inspection generally went immediately into the kill chute, where they were knocked, slaughtered, and inspected again post mortem. After passing the post mortem inspection, the carcass was tagged and could be sold.
In mid-2012, Amaral is accused of ordering Rancho employees to process cattle that were condemned by the USDA veterinarian. At his instruction, Cabrera allegedly had workers cut the “USDA Condemned” stamps out of the cattle carcasses so they could be processed for sale and distribution.
At about the same time, court documents state that Amaral gave the foreman, Cabrera, and the yardman, Corda, directions on how to circumvent inspection procedures for cows with cancerous eyes. Both Amaral and Singleton told their employees to swap out uninspected cows with cancerous eyes with cattle that had already passed ante mortem inspection, according to the documents.
“Cabrera knocked the cancer eye cows, and he or another kill floor employee at his instruction slaughtered them and deposited their heads in the gut bin,” the indictment states. “Cabrera, or another kill floor employee at his instruction, placed heads from apparently healthy cows, which had been previously reserved, next to the cancer eye cow carcasses.
“The switch and slaughter of uninspected cancer eye cows occurred during the inspectors’ lunch breaks, at a time during which plant operations were supposed to cease,” the charging documents continue. “When the inspectors returned from lunch for post mortem inspections, they were unaware that the carcasses they were inspecting belonged to cancer eye cows that had escaped ante mortem inspection.”
Based on Rancho’s records, the government figures that, from January 2013 to January 2014, beef from 101 head of condemned cattle and 79 cows with eye cancer was processed for human consumption. For every diseased animal that he got past USDA inspectors, Cabrera allegedly got a $50 bonus.
While Rancho made money by selling beef that should have been condemned, the documents state that it stopped there. They not only deducted the sales price for condemned animals from their invoices to farmers, ranchers and auction houses, they added charges for the disposal fees.
Early in the investigation, Rancho recalled all of its beef production going back for the previous year, or about 8.7 million pounds. It also was forced to close down and ultimately sell the Petaluma slaughterhouse. It has since resumed operations under new ownership.
The maximum sentences Corda and Singleton face for pleading guilty to one count each of distribution of adulterated, misbranded and uninspected meat are three years in prison and a $10,000 fine. Cooperating with the government usually brings favorable consideration at sentencing.
By contrast, if Amaral is convicted on all 11 felony counts with which he has been charged (conspiracy, mail fraud, aiding and abetting, and distributing of adulterated, misbranded, and uninspected meat), he could be looking at up to 103 years in prison and fines totaling more than $1.3 million. And if Cabrera is convicted of the eight counts he faces, he could be given a maximum of 43 years in prison and fines totaling up to $560,000.
Also, various forfeitures and special assessments could be part any sentencing.
All four men remain free on unsecured bonds. The trial date for Amaral and Cabrera will likely be set at a Dec. 17 status conference. That is also the next time that Corda is scheduled to appear. Singleton, who was was recently allowed to travel out of state for a funeral in Texas, has his next appearance scheduled on Nov. 26.
The U.S. Centers for Disease Control and Prevention (CDC) released its final update on the Salmonella Braenderup infections linked to nut butters manufactured by nSpired Natural Foods.
Six people were infected with the strain of Salmonella Braenderup since Jan. 1, 2014, in Connecticut, Iowa, New Mexico, Tennessee and Texas.
Illness onset dates ranged from Jan. 20, 2014, to May 16, 2014. Ill persons ranged in age from two years to 83 years, with a median age of 35 years. Sixty-six percent of ill persons were female. Among five ill persons with available information, one was hospitalized. No deaths were reported.
During routine inspections at an nSpired Natural Foods facility in Ashland, OR, in February and July 2014, FDA isolated Salmonella Braenderup from environmental samples. PFGE and whole-genome sequencing were performed on the environmental isolates by FDA to further characterize the bacteria.
A subsequent search of the PulseNet database identified ill persons with the same PFGE “fingerprint” of Salmonella Braenderup. Whole-genome sequencing was performed on these clinical isolates, and the bacteria from six of the ill persons were found to be related to the environmental isolates taken from the firm.
Five of the six ill persons were interviewed and answered questions about foods eaten and other exposures during the week before becoming ill. Four of them reported eating peanut or almond butter, and all four reported eating a brand of peanut or almond butter produced by nSpired Natural Foods Inc.
On Aug. 19, 2014, nSpired Natural Foods Inc. voluntarily recalled certain lots of almond and peanut butters because of potential contamination with Salmonella. The recalled brands included Arrowhead Mills, MaraNatha, Trader Joe’s, Whole Foods, Safeway and Kroger.
This outbreak investigation is now over, but the recalled nut butter products have a long shelf life and may still be in people’s homes. Consumers unaware of the recall could continue to eat the products and potentially get sick.
CDC’s National Antimicrobial Resistance Monitoring System (NARMS) laboratory conducted antibiotic-resistance testing on the Salmonella Braenderup isolates collected from four ill persons infected with the outbreak strain, and all were found to be susceptible to all antibiotics tested on the NARMS panel.
I think I am qualified to say that my friend Senator McGovern would have liked the George McGovern Lecture delivered last week in Rome by former Deputy Secretary of Agriculture Kathleen Merrigan. The lecture named for the former South Dakota senator is an annual event for the United Nations Food and Agriculture Organization in Rome. The UN food agencies in Rome grew out of President John F. Kennedy’s original “Food for Peace” program that began a half-century ago.
Although Merrigan’s time as deputy secretary of agriculture was about normal, her departure seemed unexpected and premature. That’s because her leadership and accomplishments for organic and local agriculture were unique. Merrigan was that rare person who left government with more to say. That’s what made U.S. Ambassador David Lane’s choice of Merrigan to deliver this year’s McGovern lecture an inspired choice.
And Merrigan delivered. Some people think that organic and local food should be given a break when it comes to food safety, but she made it clear in Rome that while government’s role can vary for the size and scale of the farm, not so when it comes to food safety.
Merrigan told the audience that American agriculture is more diverse than commodity production. She pointed to more organic, young, Latino, and women farmers reported by the new Census of Agriculture. As the one who brought us both the USDA organic standards and the “Know Your Farmer, Know Your Food” initiatives, Merrigan said there is “huge overlap,” but she added that, “Not all organic is local and not all local is organic.”
Merrigan also made news during the Q&A session when she said that her definition of diversity in agriculture includes genetic modification. She said she does not want young people to be “anti-technology or anti-science.”
The title of her lecture was, “Local Produce, Local Markets: Fostering Regional Agricultural Systems.” It has not yet been posted on the site of the U.S. Mission to the UN food agencies in Rome, but it will likely be there soon.
The McGovern Lecture owes its existence, ironically, to what some say was one of the worst speeches ever given on agricultural policy. McGovern liked telling the story.
Both Vice President Richard Nixon and Senator John Kennedy accepted invitations to appear at the National Corn Picking contest near Sioux Falls, SD, in October 1960.
On separate days, South Dakota GOP Senator Karl Mundt introduced the vice president, and then-Congressman McGovern introduced Kennedy. Mundt and Nixon were both viewed as experts on the farm policies of the day. By contrast, McGovern used to say that Kennedy knew just a tiny bit about Massachusetts cranberries.
On the GOP day, the sun was shining and the crowds were massive. The audience from as many as 10 states numbered around 70,000 for Nixon. But on the day Kennedy took the stage, the weather had turned mean. The wind was picking up, the temperature was dropping quickly, and skies were darkening. Kennedy would deliver his speech in a cold, dripping rain.
Worse, the speech was written by some policy wonk, and it was clear to anyone that the young Massachusetts senator did not understand what was coming out of his mouth. He knew, too. Afterward, he immediately apologized to McGovern because he was certain that his bungled agricultural speech would lead to McGovern losing South Dakota’s U.S. Senate race.
McGovern was taking Kennedy next to the Corn Palace in Mitchell, SD, to address another large farm audience. He told Kennedy to throw away the prepared speech from the ag policy experts and to instead speak from the heart. He told Kennedy to just say that Secretary of Agriculture Ezra Taft Benson says farm surpluses are a problem and that’s the wrong approach.
McGovern persuaded Kennedy to say that the abundance of American agriculture is “a great national treasure.” The theme of JFK’s Corn Palace speech was that, “Food is health, food is strength, and food is peace.” Then he promised that, if elected president of the United States, he’d create a Food for Peace Office in the White House to use farm surpluses to reduced world hunger.
JFK’s fear about McGovern losing that 1960 U.S. Senate race to Karl Mundt was correct. He went down by about 15,000 votes, but he moved into a White House office as the first director of the Food for Peace Program.
AMS Health Sciences is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters.
Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.
Product from this lot was sold to consumers through the Internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same lot number have tested negative for Salmonella.
Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund.
Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (e.g., infected aneurysms), endocarditis and arthritis.
The members — including Reps. Rosa DeLauro (D-CT) and Louise Slaughter (D-NY) — wrote that they are “extremely disappointed” that the agency didn’t address their concerns about the rule, adding that it is “detrimental to food and worker safety” and “abdicates food safety oversight from USDA.”
The letter asks Vilsack about an implementation timeline and agency plans for what happens if more (or fewer) than the expected 219 plants decide to shift to the new system, how FSIS will verify that NPIS plants are meeting requirements and producing safe food, how many positions will be displaced or eliminated, health and safety activities at the plants, and how the agency will make sure the plants adhere to animal welfare laws.
They also inquire in the letter what penalties there will be for NPIS plants involved in a foodborne illness outbreak. Specifically, the members want to know if such plants will have to give up the system.
The members request answers to their questions within 30 days so that they can further evaluate the rule.
At least 80 people fell ill this summer with Campylobacter infections linked to the consumption of unpasteurized milk from a farm in Utah, according to Utah health officials speaking with state lawmakers on Wednesday.
Health officials said that the outbreak also contributed to the death of one immunocompromised man. Twenty percent of cases were hospitalized.
The farm linked to the outbreak, Ropelato Dairy in west Ogden, had its license reinstated on Oct. 3 after testing of samples showed no more sign of contamination, according to the Salt Lake Tribune.
The state of Utah requires raw milk products to bear a label warning consumers of the potential illness risk, but Ropelato’s milk reportedly did not carry that label.
The vast majority of patients were Utah residents, though at least one was from Idaho and one from California. Ages of patients ranged from 2 to 74 years old.
Most illnesses developed between May 9 and July 21. State health officials suspended the dairy’s license to sell milk on Aug. 4.
During a legislative hearing on the outbreak, a number of Utah lawmakers reportedly said that they did not want this incident to lead to restrictions on raw milk sales in the state.
State law allows raw milk dairies in Utah to sell products directly to consumers as long as they own the store selling the products. Retail sales at stores not owned by the dairy are not allowed.
Raw milk in Utah is also subject to monthly testing for pathogens, and the animals must be tested every six months.
Oasis Brands Inc. of Miami, FL, is recalling select lots of various Lacteos Santa Martha products with best-by dates of 07/01/14 through 12/31/14 because the products have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
The recalled products were distributed in Florida, Georgia, Tennessee and North Carolina from April 1 through Oct. 14, 2014, to distributors and retail stores. The products can be identified by the batch ID code (best-used-by date) sticker on the label of the plastic bag of 07/01/14 through 12/31/14.Queso Seco Centroamericano (Dry White Cheese) 1Lb UPC 876593 001874 Queso Seco Olanchano (Dry Cheese) 1Lb UPC 635349 000840 Queso Seco Hondureno (Dry Cheese) 12oz UPC 876593 001690 Quesito Casero (Fresh Curd) 12oz UPC 635349 000406 My Queso (Latin Flavor Cheese) 1Lb UPC 635349 000406 Queso Cuzcatlan (Salvadorean Flavor Cheese) 1Lb UPC 635349 000406 Queso para Freir (Cheese for Frying) 12oz UPC 635349 000758 Queso Fresco (Fresh Cheese) 12oz UPC 635349 000703 Cuajada en Hoja Queso Casero Hecho a Mano (Fresh Curd) 12oz UPC 635349 000895 Crema Centroamericana (Soft Blend Dairy Spread) 1Lb UPC 876593 001898 Mantequilla Hondurena (Honduran Style Cream) 1Lb UPC 635349 000772 Crema Nica (Grade A Cultured Cream) 1Lb UPC 635349 000468 HonduCrema Olanchana (Olanchana Style Soft Blend Dairy Spread) 1Lb UPC 635349 000598 Crema Guatemalteca (Guatemalan Style Cream) 1Lb UPC 635349 000819 Crema GuateLinda (Guatemalan Style Cream) 1Lb UPC 635349 000390 Crema Cuzcatlan (Salvadorean Style Cream) 1Lb UPC 635349 000444
FDA is investigating illnesses associated with the product.
The recall is the result of routine sampling by the Virginia Department of Agriculture and Consumer Services Food Inspectors and subsequent FDA environmental samples that revealed the presence of Listeria monocytogenes. The company ceased production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.
Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
A judge has upheld citations for a NY-based chicken processor found to be violating rules related to chemical and mechanical hazards for workers. The citations were issued by the U.S. Department of Labor’s Occupational Safety & Health Administration (OSHA).
Murray’s Chicken, of South Fallsburg, NY, was cited in May 2012 for a number of worker safety and health violations. According to OSHA, the company failed to inform employees about the hazards of products that contain peracetic acid and bleach and also failed to train employees who worked with machines that could unexpectedly start up.
“This is a critical decision that this employer and others in the industry should pay close attention to,” said Robert Kulick, OSHA’s regional administrator in New York. “Not informing production employees that the chemical hazards they worked with exposed them to potential illness, or that the absence of machine maintenance procedures left them vulnerable to lacerations, amputations or death, is unacceptable and will be enforced to the highest extent of the law.”
Employees of the company had told an OSHA compliance officer that they had experienced symptoms of respiratory ailment and rashes consistent with exposure to harsh acidic chemicals and chlorine bleach.
The judge also agreed with OSHA that the company’s machine maintenance procedures lacked sufficient detail to protect employees from serious injury while working with the equipment. Employees were not given basic training on how to avoid such injuries, and two employees were injured after attempting to perform maintenance on equipment without proper safety knowledge.
The petitions target perchlorate, which is added to sealing gaskets for food containers and to reduce static in dry food packaging, and a family of chemicals known as long-chain perfluorocarboxylates (PFCs) that keep grease out of paper and paperboard, such as pizza boxes and sandwich wrappers.
These chemicals have the potential to harm fetal development, male reproductive systems, pre- and post-natal brain development and cause cancer, stated the petition signatories. They are the Natural Resources Defense Council (NRDC), Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Children’s Environmental Health Network, Clean Water Action, Environmental Working Group, and Improving Kids’ Environment.
The perchlorate petition stemmed, in part, from data NRDC received from a Freedom of Information Act request for scientific assessments FDA used to grant approval for the chemical’s use in 2005. The groups argue that the agency’s data were flawed.
The petitioners cited an FDA study from 2008 which found that 59 percent of more than 1,000 food samples had detectable levels of perchlorate and that children younger than six had the greatest average exposure.
They also emphasized that the Environmental Protection Agency’s Science Advisory Board believes that infants are likely to be disproportionately impacted by perchlorate because their brains are still developing.
FDA had previously asked three companies to stop using certain PFCs in their food packaging. The companies agreed, but the chemicals can still be used in products made overseas and shipped back to the U.S.
In the petition, the groups said they found at least 10 animal studies published between 2009 and 2014 that supported FDA’s toxicology conclusions that there are “significant gaps” in our knowledge about the safety of PFCs.
For much of the country, as the temperatures drop, there is increased activity of mice to find a harborage area. For any food operation, or homeowner, for that matter, this means an increased potential of infestation if some proactive measures are not taken to eliminate entry. Here are a few suggestions:
1. Think like a mouse.
2. Any hole, gap or crack leading directly outside must be either sealed or flush with the floor. If you see sunlight, chances are that gap may be large enough for a mouse to squeeze through. Simply using some type of spray foam to plug a hole may work temporarily until the mice decide to chew through it, so put a metal scrub pad in the hole before it is sealed. I’ve seen mice tunnel through fireproof insulation three floors high, chew through wires, sheetrock, plaster and plywood, so they are resilient and can get to where they want to go.
3. Keep doors closed when not in use, especially in a warehouse next to a field, where even Bigfoot can walk right in.
4. Be careful of potential exterior harborage areas. Those hay bales — yes, they’re very fall-like and a nice-looking Halloween decoration — but they’re also a nice, warm and comfortable area for mice to inhabit. Bags of mulch and even vending machines are as well. Just keep that in mind the next time your dispensed scratch-off lottery ticket looks like it has been nibbled on the end. Those make perfect nesting material, and the grand prize you might win may have four legs.
5. Be mindful of any potential outdoor food source that can be an attraction, such as an unkept garbage area, seed, pet food and anything else that will attract rodents.
6. Make sure to thoroughly check any food and/or paper deliveries for evidence of infestation. Is one of your vendors possibly bringing you something more than you bargained for?
7. Finally, ask yourself: Just exactly what are those holes in the ground outside your back door?
Mice can be a big problem once they have gained access to your interior, not only for the spread of potential disease, product loss, damage to reputation, citations and/or fines from the health department, but also for the money you will spend in labor to clean up after them and for the pest-control company to get rid of them.
Keep in mind that, with a potential reproduction rate of five to 10 litters a year, times five to six babies each, an unchecked mouse population can grow fast. And it all starts with entry.